Phase 3
N=1,029
Exenatide Versus Glimepiride in Patients With Type 2 Diabetes
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00359762 ↗Enrolled (actual)
1,029
Serious AEs
13.5%
Results posted
Mar 2013
Primary outcome: Primary: Number of Patients With Treatment Failure — 203; 262; 287; 225 number of patients — p=0.0020
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- exenatide (Drug); glimepiride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Treatment Failure |
203; 262; 287; 225 | 0.0020 sig |
| PRIMARY Time to Treatment Failure |
180.0; 142.1 | 0.0315 sig |
| SECONDARY Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3 |
66.86; 68.52 | 0.7648 |
| SECONDARY Change in HOMA-B From Baseline to Endpoint |
5.56; 19.92 | 0.0528 |
| SECONDARY Fasting Proinsulin/Insulin Ratio at Year 3 |
0.22; 0.23 | 0.9040 |
| SECONDARY Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint. |
0.03; 0.05 | 0.2500 |
| SECONDARY Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3 |
25.81; 26.38 | 0.9001 |
| SECONDARY Change in DI30/DG30 Ratio From Baseline to Endpoint |
12.10; 0.91 | 0.0246 sig |
| SECONDARY Disposition Index at Year 3 |
12.56; 7.89 | 0.0036 sig |
| SECONDARY Change in Disposition Index From Baseline to Endpoint |
9.15; 1.82 | 0.0006 sig |
| SECONDARY Change in HbA1c From Baseline to Year 3 |
-0.30; -0.12 | 0.0128 sig |
| SECONDARY Change in HbA1c From Baseline to Endpoint |
-0.36; -0.21 | 0.0015 sig |
| SECONDARY Fasting Plasma Glucose at Year 3 |
7.27; 7.96 | <.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose From Baseline to Endpoint |
-0.87; -0.41 | 0.0109 sig |
| SECONDARY Postprandial (2 Hours) Plasma Glucose at Year 3 |
12.65; 15.45 | <.0001 sig |
| SECONDARY Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint |
-2.72; -0.53 | <.0001 sig |
| SECONDARY Change in Body Weight From Baseline to Year 3 |
-3.92; 1.47 | <.0001 sig |
| SECONDARY Systolic Blood Pressure at Year 3 |
130.58; 135.78 | <.0001 sig |
| SECONDARY Diastolic Blood Pressure at Year 3 |
77.45; 79.16 | 0.0228 sig |
| SECONDARY Heart Rate at Year 3 |
73.51; 74.23 | 0.3737 |
| SECONDARY Triglycerides at Year 3 |
1.69; 1.95 | 0.0042 sig |
| SECONDARY Total Cholesterol at Year 3 |
4.77; 4.75 | 0.7914 |
| SECONDARY High-density Lipoprotein (HDL) Cholesterol at Year 3 |
1.31; 1.25 | 0.0011 sig |
| SECONDARY Hypoglycemia Rate Per Year |
1.52; 5.32 | <.0001 sig |
| SECONDARY Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III |
-0.19; -0.47 | 0.0508 |
| SECONDARY Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III |
-0.47 | — |
| SECONDARY Hypoglycemia Rate Per Year in Period III |
2.78; 0.60; 4.62 | — |
Summary
This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 2 diabetes mellitus.
- Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
- HbA1c >=6.5% and =25 kg/m^2 and <40 kg/m^2.
Exclusion Criteria
- Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
- Characteristics contraindicating metformin or glimepiride use.
- Receiving drugs that directly affect gastrointestinal motility.
- Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
- Have used any prescription drug to promote weight loss within 3 months prior to screening.
- Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: *insulin; *thiazolidinediones; *alpha-glucosidase inhibitors; *sulfonylurea; *meglitinides
Data sourced from ClinicalTrials.gov (NCT00359762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.